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Need help? Call Us: 07917257301
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Cyproheptadine, USP

Cyproheptadine, USP

Cyproheptadine, USP, is a first-generation antihistamine medication used primarily to relieve allergy symptoms such as hay fever, urticaria (hives), and other allergic conditions. It functions by antagonizing histamine H1-receptors, thereby reducing allergic responses. Additionally, Cyproheptadine has anticholinergic and antiserotonergic properties, which contribute to its effects on appetite stimulation and migraine prevention. It is available in various formulations, including tablets, syrup, and injections, and is prescribed under medical supervision to manage allergic and other related conditions.

Category:

Description

  1. Description:
    A white or almost white crystalline powder.
  2. Identification:
    • Confirmed by IR spectrophotometry (matching the reference spectrum).
    • Positive tests for specific functional groups as per USP monograph.
  3. Assay (Content):
    • Not less than 99.0% and not more than 102.0% of C18H21N·HCl, calculated on the dried basis.
  4. Loss on Drying:
    • Not more than 0.5% (determined by drying at 105°C for 3 hours).
  5. Residue on Ignition:
    • Not more than 0.1% (as per USP requirements).
  6. Heavy Metals:
    • Not more than 10 ppm (using atomic absorption spectroscopy or equivalent method).
  7. Microbial Limits:
    • Total Aerobic Microbial Count: Not more than 1000 CFU/g.
    • Yeasts and Molds: Not more than 100 CFU/g.
    • Absence of specific pathogens (e.g., Salmonella, Escherichia coli).
  8. Chromatographic Purity:
    • Confirmed by HPLC or TLC to ensure purity and detect any impurities or degradation products.
  9. pH (for solutions):
    • Appropriate pH range for formulations, typically between 4.5 and 6.0.

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Cyproheptadine, USP

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